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Common Mistakes Made When Setting Up an Environmental Monitoring Program
Wednesday 23rd January 2019

Learn about the common mistakes when setting up an environmental monitoring program that can lead to missing product contamination risk or excessive excursions. Learn how to apply appropriate standards, guidance and science to ensure that the program meets regulatory requirements and is effective in assessing risk to product. Additionally, learn about barrier system issues, misdiagnosed airflows, inadequate choice of monitoring equipment (specification etc.), media management gaps, and perceived vs actual risk assessment that can affect contamination detection.

Workshop Leaders:
Ziva Abraham, CEO, Microrite
Morgan Polen, Contamination Control and Cleanroom Expert, Microrite

Ziva Abraham is the President and Founder of Microrite, Inc., a California based consulting firm providing consulting and training services to pharmaceuticals, biotechnology, medical devices and in vitro diagnostics in the areas of quality assurance, quality control, microbiology, and validation.
Ziva has over 25 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva has received her Master’s Degree in microbiology with a focus on Mycology and has conducted research on developing microbial Insecticides using entomogenous bacteria and fungi for her PhD degree. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel. She has trained personnel from various industries in microbiology techniques and methods. She uses her extensive experience to teach why assessing risk of microbial contamination should be in the forefront of any company that has products for human/veterinary use. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective.

Morgan Polen has been involved with cleanrooms and contamination control since 1984. He has worked in over 40 countries involved with projects ranging from cleanroom design, construction, validation, AFV, monitoring program development, particle counter design and product management for cleanroom related products and systems. He has addressed monitoring and control solutions in a wide variety of clean industries such as pharmaceutical, medical device, semiconductor, data storage, aerospace, defense, automotive, optical and others. Morgan is a member of IEST’s US Technical Advisory Group to ISO/TC 209 Cleanrooms and Associated Controlled Environments, participating in the process of adapting the latest cleanroom standards.
 

The purpose of an environmental monitoring program is to detect particulate and microbial contamination risk to product. This cannot be accomplished if the cleanroom and barrier system flaws are not known, collection efficacy of monitoring devices is not understood, quality of microbiological media is not comprehended and the sites that pose real risk to product are not realized.
Multiple case studies will be utilized as examples related to deficient Environmental Monitoring Programs which have led to 483 observations, warning letters and data integrity issues.
 

Workshop programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

9:10 Case studies for understanding barrier system flaws

Ziva Abraham

Ziva Abraham, CEO, Microrite, Inc.

  • Barrier system design and integration flaws that led to environmental monitoring excursions and data integrity issues leading to a warning letter and export ban
  • How not understanding cleanroom standards led to excessive monitoring of an OSD facility, leading to consistent failures and generation of fraudulent data
  • Improperly performed smoke studies leading to false sense of control; EM excursions showed otherwise
  • Inadequate Air Flow Visualization Studies leading to incorrect monitoring locations
  • 9:50 Evaluation of environmental monitoring devices

    Morgan  Polen

    Morgan Polen, Contamination Control and Cleanroom Expert, Microrite, Inc.

  • Learn from current FDA observations related to particle loss in particle monitoring devices
  • Points to consider when choosing particle & active air samplers; understand technologies and risks
  • 10:30 Morning Coffee

    11:00 Media quality and management

    Ziva Abraham

    Ziva Abraham, CEO, Microrite, Inc.

  • False positive and false negative results directly related to media quality and management
  • FDA 483s related to media quality and inadequate use
  • 11:40 Real risk vs perceived risk when choosing environmental monitoring sites

    Morgan  Polen

    Morgan Polen, Contamination Control and Cleanroom Expert, Microrite, Inc.

  • 483 observations related to risk-based sampling site selection
  • How to utilize airflow visualization to identify sampling sites which pose a real risk to product
  • 12:20 Group Exercise: Group discussion on various risk assessment strategies used for EM site selection; what worked and what did not

    13:00 Closing Remarks and End of Workshop

    +

    FEATURED SPEAKERS

    Morgan  Polen

    Morgan Polen

    Contamination Control and Cleanroom Expert, Microrite, Inc.
    Ziva Abraham

    Ziva Abraham

    CEO, Microrite, Inc.

    Morgan Polen

    Contamination Control and Cleanroom Expert, Microrite, Inc.
    Morgan  Polen

    Ziva Abraham

    CEO, Microrite, Inc.
    Ziva Abraham

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    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

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    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

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